FDA approves orphenadrine

September 9, 2011

FDA has approved orphenadrine citrate injection, USP (Sagent Pharmaceuticals) a skeletal muscle relaxant as an adjunct to rest, physical therapy, and other measures to support relief from acute, painful musculoskeletal conditions.

FDA has approved orphenadrine citrate injection, USP (Sagent Pharmaceuticals), a skeletal muscle relaxant as an adjunct to rest, physical therapy, and other measures to support relief from acute, painful musculoskeletal conditions.

Orphenadrine will be offered in 60 mg per 2 mL single-dose, latex-free vials.

Orphenadrine is an anticholinergic drug, marketed under various brand names, for treating painful muscle spasms and other similar discomforts. According to 2011 IMS data, the US injectable market for orphenadrine approximated $4.3 million.

Orphenadrine features the Sagent's PreventIV Measures packaging and labeling, designed to aid in the reduction of medication errors.

FDA’s approval closely follows the launch of another injectable therapy at Sagent-vecuronium bromide as an adjunct to general anesthesia. Vecuronium, a neuromuscular blocking agent, was launched in 10- and 20-mg single-use vials.

Sagent expects to launch orphenadrine in the third quarter of 2011.